Study Operations Manager I (cSOM1)

Pharmaceutical Research Associates, Inc; Canada; Remote; CAD 60,000 - 100,000; Full time

Job summary

Join a leading clinical research organization as a C-SOM, where you will manage and oversee study activities at regional and country levels. This role involves ensuring compliance with regulations, coordinating with global teams, and utilizing country intelligence for risk management. You will play a crucial part in supporting site recruitment and managing quality events, all while being part of an inclusive and dynamic environment that values your contributions. With a competitive salary and a range of benefits tailored to your needs, this position offers a fantastic opportunity to advance your career in clinical research.

Benefits

Health insurance

Retirement plans

Employee assistance programs

Flexible options

Qualifications

• 5+ years of experience in operational clinical trials.
• Knowledgeable in Good Clinical Practice and regulatory environments.

Responsibilities

• Manage study activities from startup through conduct and closeout.
• Coordinate with teams on submission strategies and site activation.

Skills

Operational clinical trials

Good Clinical Practice

Regulatory environments

Project management

Education

BA/BS in a scientific or technical field

MBA/MS

Tools

Site Technology systems

Job description

Overview

As a C-SOM, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Manage and oversee study activities at regional and country levels from startup through conduct and closeout.
• Manage study startup processes in assigned countries and oversee pCRO activities where applicable.
• Support site identification, feasibility, and outreach processes to ensure study protocol requirements are met.
• Provide input on startup and recruitment milestones to the Global Study Manager.
• Oversee pCRO and/or Country Trial Managers at the country level, maintaining accurate plans and managing risks and deviations.
• Lead the Local Study Team, ensuring compliance with regulations and timely communication.
• Coordinate with country and global teams on submission strategies, regulatory submissions, and site activation.
• Utilize country intelligence for risk management and quality oversight.
• Ensure audit/inspection readiness and manage quality events.
• Coordinate site recruitment, data cleaning, and budget considerations.
• Support implementation of Pfizer's Site Technology systems.
• Assist with regulatory submissions and document management.
• Support vendor management, investigator meetings, and site management activities.

Qualifications

You are:

• Experienced in operational clinical trials.
• Possess a scientific or technical degree; BA/BS with 5+ years, or MBA/MS with 3+ years of relevant experience.
• Knowledgeable in Good Clinical Practice and regulatory environments.
• Proficient in English.

What ICON can offer you:

• Competitive salary and benefits tailored to each country.
• Additional benefits such as health insurance, retirement plans, employee assistance programs, and flexible options.

Visit our careers website for more details: https://careers.iconplc.com/benefits

We are committed to inclusion and equal opportunity for all applicants.